BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060058 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05837
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE (FR) INDICATED THAT THE LEAD HAD FRACTURED. THE PATIENT HAD BEEN PULLING A TIRE OFF OF A GOLF CART AND THE TIRE HIT HIM IN THE CHEST. THE LEAD WAS EXPLANTED AND IS TO BE RETURNED FOR ANALYSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FOR A HIGH, OUT OF RANGE RIGHT VENTRICULAR PACE IMPEDANCE MEASUREMENT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS OF TODAY, THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R T125| E110| 4470| 0158